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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Madsen Astera 2 - 05713315010187

1066 MADSEN Astera 2, US Only
Natus Medical Denmark ApS
8-04-13402
In Commercial Distribution

  • 05713315010187 ()
8-04-13402

  • Speech audiometer

MADSEN Astera 2 - 05713315007859

1066 MADSEN Astera 2 with ACPDS, Including HB-7 Headset, Insert Phone and DD450
Natus Medical Denmark ApS
8-04-13104
In Commercial Distribution

  • 05713315007859 ()
8-04-13104

  • Speech audiometer

MADSEN Astera 2 - 05713315007521

1066 MADSEN Astera 2 with ACP, ISO Calibration Incl. ME70 Headset and BC-1 Bone conductor
Natus Medical Denmark ApS
8-04-13124
In Commercial Distribution

  • 05713315007521 ()
8-04-13124

  • Speech audiometer

MADSEN Astera 2 - 05713315007477

1066 MADSEN Astera 2 without ACP ANSI Cal.Incl. ME70 Headset, Insert Earphone, BC-1 BC
Natus Medical Denmark ApS
8-04-12118
In Commercial Distribution

  • 05713315007477 ()
8-04-12118

  • Speech audiometer

MADSEN Astera 2 - 05713315007439

1066 MADSEN Astera 2 w/ACP, ISO Cal. HB-7, Insert phone, DD450, B71 BC, Wall Mount Kit
Natus Medical Denmark ApS
8-04-13128
In Commercial Distribution

  • 05713315007439 ()
8-04-13128

  • Speech audiometer

MADSEN Astera 2 - 05713315007415

1066 MADSEN Astera 2 with ACP, ISO Cal. Incl. HB-7 Headset, B71 BC and Wall Mounting Kit
Natus Medical Denmark ApS
8-04-13127
In Commercial Distribution

  • 05713315007415 ()
8-04-13127

  • Speech audiometer

KLS MaxDriver 2 - 00856482008115

No Description
PRO-DEX, INC.
KLS-SD-2000
In Commercial Distribution

  • 00856482008115 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

SureEase Comfort 2 - 00852598007257

Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007257 ()


  • Penile vacuum device

Lapiplasty System 2 - 00853114006105

Long Screw Pack
Treace Medical Concepts, Inc.
SD16
In Commercial Distribution

  • 00853114006105 ()


  • Orthopaedic bone screw (non-sliding)

Lapiplasty System 2 - 00853114006051

Anatomic Biplanar Implants
Treace Medical Concepts, Inc.
SK14
In Commercial Distribution

  • 00853114006051 ()


  • Orthopaedic fixation plate, non-bioabsorbable
  • Orthopaedic bone screw (non-sliding)

aBox™ 2 - 05707480156207

Ambu aBox 2 US1
Ambu A/S
505001000US1
In Commercial Distribution

  • 05707480156207 ()
505001000US1

  • Endoscopic video image display unit

DirectView 2 Mirror - 00850054345226

No Description
Ion Vision, Inc
P-IOV-023
In Commercial Distribution

  • 00850054345226 ()


  • Surgical camera lens

LAVA-34, 2 mL - 00850055697010

LAVA Liquid Embolic System (LES) Kit, LAVA-34, 2 mL
Blackswan Vascular, Inc.
SLLES342
In Commercial Distribution

  • 00850055697010 ()


  • Non-neurovascular embolization plug, synthetic polymer

LAVA-18, 2 mL - 00850055697003

LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL
Blackswan Vascular, Inc.
SLLES182
In Commercial Distribution

  • 00850055697003 ()


  • Non-neurovascular embolization plug, synthetic polymer

Matrix Max 2 - 00645517844886

Matrix Max 2 Trimmable AFO (X Large Right)
TRULIFE LIMITED
FH260R05
In Commercial Distribution

  • 00645517844886 ()


  • Ankle/foot orthosis

Matrix Max 2 - 00645517844879

Matrix Max 2 Trimmable AFO (Large Right)
TRULIFE LIMITED
FH260R04
In Commercial Distribution

  • 00645517844879 ()


  • Ankle/foot orthosis

Matrix Max 2 - 00645517844862

Matrix Max 2 Trimmable AFO (Medium Right)
TRULIFE LIMITED
FH260R03
In Commercial Distribution

  • 00645517844862 ()


  • Ankle/foot orthosis

Matrix Max 2 - 00645517844855

Matrix Max 2 Trimmable AFO (Small Right)
TRULIFE LIMITED
FH260R02
In Commercial Distribution

  • 00645517844855 ()


  • Ankle/foot orthosis

Matrix Max 2 - 00645517844848

Matrix Max 2 Trimmable AFO (X Large Left)
TRULIFE LIMITED
FH260L05
In Commercial Distribution

  • 00645517844848 ()


  • Ankle/foot orthosis

Matrix Max 2 - 00645517844831

Matrix Max 2 Trimmable AFO (Large Left)
TRULIFE LIMITED
FH260L04
In Commercial Distribution

  • 00645517844831 ()


  • Ankle/foot orthosis
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